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# Iovance Bio Gets Priority Review for Melanoma BLA
- URL: https://www.fdaweb.com/iovance-bio-gets-priority-review-for-melanoma-bla/
- Published: 2023-05-30T12:00:00.000Z
- Updated: 2026-09-14T18:35:04.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154561

FDA has accepted for priority review an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The company is seeking accelerated approval from FDA, which has set a user fee review action target date of 11/25\. The agency told the company that it is not planning to convene an advisory committee meeting to discuss the submission, according to Iovance.

The submission is based on clinical [data](https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-updated-clinical-data-0?ref=fdaweb.com) from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. “If lifileucel receives accelerated approval, the randomized Phase 3 [TILVANCE-301](https://clinicaltrials.gov/ct2/show/NCT05727904?term=IOV-MEL-301&draw=2&rank=1&ref=fdaweb.com) trial in frontline advanced melanoma can serve as the confirmatory study to support full approval,” the company says. “TILVANCE-301 is expected to be well underway at the time of approval.”